Navigation Links
Johnson & Johnson Provides Update on McNeil Consumer Healthcare Remediation; Announces Completion of Internal Assessment Phase of Comprehensive Action Plan
Date:1/14/2011

NEW BRUNSWICK, N.J., Jan. 14, 2011 /PRNewswire/ -- McNeil Consumer Healthcare Division of McNeil-PPC, Inc., a Johnson & Johnson (NYSE: JNJ) company, in July 2010 submitted to the FDA a Comprehensive Action Plan on quality improvement, and made a commitment to restore its operations to the level of quality and compliance that people expect of all Johnson & Johnson companies. As part of this commitment, McNeil undertook a thorough investigation of historical records, as far back as 2007, for products sold in the U.S. and produced in McNeil's internal manufacturing network.  For each product, McNeil looked at whether the right processes had been identified and followed, and evaluated whether quality standards had been met. This assessment has now been completed, representing a significant milestone in the Comprehensive Action Plan.  

The assessment identified a number of areas for improvement, which are being addressed. For example, McNeil identified instances where equipment cleaning procedures were insufficient or cleaning was not adequately documented. These issues occurred at McNeil's Fort Washington, PA manufacturing plant, prior to April 2010, when production at the facility was suspended. McNeil also discovered one product for which the labeling did not include all information required by regulations.  In line with the company's unqualified commitment to quality and compliance, McNeil today announced a wholesale-level recall of products affected by these issues. (Click HERE to access recall information.) This recall does not come as a result of adverse events.

Johnson & Johnson Chairman and CEO Bill Weldon said, "Steps we have taken under the Comprehensive Action Plan constitute an uncompromising and systematic effort to review quality and manufacturing practices at McNeil. They help us assure that moving forward, any of our products in the marketplace live up to the trusted standards and expectations that consumers have for all products coming from a Johnson & Johnson company, anywhere in the world."

As a continuing part of this effort, McNeil is conducting assessments at other sites that manufacture its products.  If these reviews reveal any further issues, McNeil will not hesitate to take whatever steps are needed to ensure that its products meet world-class quality standards, including further market action if warranted.

McNeil is committed to ensuring the highest levels of quality, and to restoring recalled products to the market so they will be available to the people who rely on them.  


'/>"/>
SOURCE Johnson & Johnson
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Johnson & Johnson to Provide Webcast Presentation of Tapentadol Phase 3 Clinical Data Presented at American Pain Societys Annual Meeting
2. Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Announces FDA Filings for Paliperidone Palmitate and INVEGA(R)
3. Simbionix and Johnson & Johnson LLC Announce Distribution Agreement at Russia and the CIS Countries
4. Johnson & Johnson Announces Support for Kohl-Grassley Physician Payments Sunshine Act of 2009
5. Boston Scientific and Johnson & Johnson Announce Settlement of Patent Disputes
6. Palomar to Commercialize FDA Cleared Over-The-Counter Home Use Wrinkle Treatment Laser Device Without Johnson & Johnson
7. U.S. Files Suit Against Johnson & Johnson For Paying Kickbacks to Nations Largest Nursing Home Pharmacy
8. EF Johnson Technologies Announces Third Quarter Results
9. Emerging Agents from Theravance/Astellas, Johnson & Johnson/Basilea and Forest/Astrazeneca/Takeda Will Drive Modest Growth in the MRSA Drug Market Through 2018
10. Johnson & Johnson to Participate in the 30th Annual Cowen and Company Health Care Conference
11. Two Johnson & Johnson Subsidiaries to Pay Over $81 Million to Resolve Allegations of Off-Label Promotion of Topamax
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... 24, 2016   Pulmatrix, Inc ., (NASDAQ: ... inhaled drugs, announced today that it was added to ... its comprehensive set of U.S. and global equity ... an important milestone for Pulmatrix," said Chief Executive Officer ... of our progress in developing drugs for crucial unmet ...
(Date:6/23/2016)... June 23, 2016 Research and Markets ... Market - Forecast to 2022" report to their offering. ... method for the patients with kidney failure, it replaces the ... from the patient,s blood and thus the treatment helps to ... chloride in balance. Increasing number of ESRD ...
(Date:6/23/2016)... -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that ... PCT (procalcitonin) assay as a dedicated testing solution for ... clearance, Roche is the first IVD company in the ... risk assessment and management. PCT is a ... in blood can aid clinicians in assessing the risk ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... ... professionals, announced today its affiliation with Tennessee Counseling Association. This new ... network of the Tennessee Counseling Association, adding exclusive benefits and promotional offers. , ...
(Date:6/27/2016)... ... 27, 2016 , ... TopConsumerReviews.com recently awarded their highest five-star rating to Best ... individuals in the United States and Canada wear eyeglasses. Once considered to be a ... and make a fashion statement. Even celebrities use glasses as a way of creating ...
(Date:6/26/2016)... ... 26, 2016 , ... Pixel Film Studios Released ProSlice Levels, a Media Slicing ... their videos a whole new perspective by using the title layers in ProSlice ... , ProSlice Levels contains over 30 Different presets to choose from. FCPX ...
(Date:6/26/2016)... Orion, Clarkston, Michigan (PRWEB) , ... June 26, ... ... with respect to fertility once they have been diagnosed with endometriosis. These women ... intercourse but they also require a comprehensive approach that can help for preservation ...
(Date:6/25/2016)... ... ... temporary closing of Bruton Memorial Library on June 21 due to a possible lice infestation, ... aspect of head lice: the parasite’s ability to live away from a human host, and ... necessary one in the event that lice have simply gotten out of control. , As ...
Breaking Medicine News(10 mins):